The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Xs Dynamis, Xp Dynamis, Sp Dynamis, Xp Spectro, Sp Spectro.
| Device ID | K182088 |
| 510k Number | K182088 |
| Device Name: | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Fotona D.o.o. Stegne 7 Ljubljana, SI 1000 |
| Contact | Marko Berdajs |
| Correspondent | Marko Berdajs Fotona D.o.o. Stegne 7 Ljubljana, SI 1000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-10-31 |
| Summary: | summary |